A Phase 1, Relative Bioavailability Study of Bimagrumab (LY3985863) Test and Reference Materials, and Bimagrumab Test Material Coadministration and Coformulation With Tirzepatide (LY900042), in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test Material
研究概览
简要总结
The main purpose of this study is to evaluate the body concentration of different forms of bimagrumab, administered alone or with tirzepatide. Participation in the study will last about 4.5 months, including screening and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are considered healthy as determined by medical evaluation including medical history and physical examination
- •Have a body mass index (BMI) within the range of 22.0 to 30.0 kilograms per square meter (kg/m2), inclusive
排除标准
- •Have current or a history of pancreatitis or hepatitis
- •Have a self-reported increase or decrease in body weight, greater than 5 kilograms (kg), within 3 months prior to screening
- •Have uncontrolled high blood pressure
- •Have taken medications or alternative remedies to promote weight loss within 3 months prior to screening
研究组 & 干预措施
Bimagrumab Dose 1 Reference Material
Participants will receive a single dose of bimagrumab subcutaneously (SC)
干预措施: Bimagrumab (Drug)
Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration)
Participants will receive a single dose of bimagrumab SC and a single dose of tirzepatide SC
干预措施: Bimagrumab (Drug)
Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration)
Participants will receive a single dose of bimagrumab SC and a single dose of tirzepatide SC
干预措施: Tirzepatide (Drug)
Bimagrumab Dose 1 Test Material + Tirzepatide (Coformulation)
Participants will receive a single dose of bimagrumab with tirzepatide SC
干预措施: Bimagrumab + Tirzepatide Coformulation (Drug)
Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration)
Participants will receive bimagrumab SC and tirzepatide SC for 4 weeks
干预措施: Bimagrumab (Drug)
Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration)
Participants will receive bimagrumab SC and tirzepatide SC for 4 weeks
干预措施: Tirzepatide (Drug)
Bimagrumab Dose 2 Test Material + Tirzepatide (Coformulation)
Participants will receive bimagrumab with tirzepatide SC for 4 weeks
干预措施: Bimagrumab + Tirzepatide Coformulation (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test Material
时间窗: Predose through Week 13
PK: Cmax of Bimagrumab Reference Material
时间窗: Predose through Week 13
PK: Cmax of Bimagrumab Coadministered with Tirzepatide
时间窗: Predose through Week 13
PK: Cmax of Tirzepatide Coadministered with Bimagrumab
时间窗: Predose through Week 16
PK: Cmax of Bimagrumab Coformulated with Tirzepatide
时间窗: Predose through Week 16
PK: Cmax of Tirzepatide Coformulated with Bimagrumab
时间窗: Predose through Week 16
PK: Area Under the Curve from Zero to Infinity AUC (AUC(0-∞)) of Bimagrumab Test Material
时间窗: Predose through Week 13
PK: AUC(0-∞) of Bimagrumab Reference Material
时间窗: Predose through Week 13
PK: AUC(0-∞) of Bimagrumab Coadministered with Tirzepatide
时间窗: Predose through Week 13
PK: AUC(0-∞) of Tirzepatide Coadministered with Bimagrumab
时间窗: Predose through Week 16
PK: AUC(0-∞) of Bimagrumab Coformulated with Tirzepatide
时间窗: Predose through Week 16
PK: AUC(0-∞) of Tirzepatide Coformulated with Bimagrumab
时间窗: Predose through Week 16
次要结局
未报告次要终点